Early detection and diagnosis of injury and/or disease in a subject can be key to preventing irreversible damage and death. In many cells, organs and systems, signs and symptoms which are currently accepted as indicative of injury and/or disease are not apparent until later than desirable, e.g. after symptoms negatively affect the subject, after irreversible damage has occurred, and/or after the disease has become widespread and difficult to treat.
For example, diagnosing renal dysfunction such as kidney injury early is key to appropriate treatment and prevention of irreversible damage to the kidney. Currently available assays for kidney injury are based on waste product accumulation in the blood, such as assays for creatinine and urea nitrogen in the blood of a subject suspected of having kidney injury. Diagnosis made based on measurement of these assays miss the therapeutic window for effective treatment of kidney injury.
The incidence of acute kidney injury (AKI) is increasing world-wide, affecting about 6% of all hospitalized patients in whom it is an independent predictor of mortality and morbidity. In the critical care setting, the prevalence of AKI requiring dialysis is about 6%, with a mortality rate exceeding 60%. Once established, the treatment is largely supportive, at an annual cost surpassing $10 billion in the US alone.
The diagnosis of AKI currently depends on detection of reduced kidney function by the rise in serum creatinine concentration, which is a delayed and unreliable measure in the acute setting. Ironically, experimental studies have identified interventions that may prevent or treat AKI if instituted early in the disease process, well before the serum creatinine rises. The lack of early predictive biomarkers has impaired the use of such early treatments for AKI.
Methods and compositions to treat, accurately detect and diagnose pathological diseases and conditions are required.